Anti-aging Repairing Serum: Efficacy and Tolerability Study

This experimental, mono-centric, open clinical trial was conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice (GCP).

Quality control was applied to each stage of data handling to ensure that clinical data were generated, collected, processed, analyzed and reported according to the protocol, Standard Operating Procedures (SOP) and requirement of GCP.

Descriptive Statistics: Quantitative parameters, or those that can be reasonably treated as such, were summarized using measures of central tendency as mean and median and dispersion measures as standard deviation at each time of evaluation. Quantitative variables were summarized using frequencies and percentages. For each parameter (clinical evaluation scores and parameters derived from the Primos®) and each region (frontal, periocular, peri-oral and neck), graphical representations of means ± 95% Confidence Interval (CI) were elaborated for visual assessment of evolution over time.

Inclusion criteria

• phototype I to IV
• presenting wrinkles on the forehead and/or peri-orbital area with grade ≥ 2 and ≤4 according to "Skin Aging Atlas"
• participant has not used any anti-aging products or performed aesthetic procedures over the last three months

Exclusion criteria

• pregnant, breastfeeding or immune compromised woman
• participant with cutaneous marks or active dermatoses on the tested area that could interfere with the evaluation